FDA UDI
In Commercial Distribution
🇺🇸 United States
SURFLO MIDELA
DI: 36927675520754
·
Model: MCS2008D01F
·
Terumo Medical Products (Hangzhou) Co., Ltd.
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
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Basic Information
- Brand Name
- SURFLO MIDELA
- Primary DI
- 36927675520754
- Version / Model
- MCS2008D01F
- Catalog Number
- MCS2008D01F
- Company Name
- Terumo Medical Products (Hangzhou) Co., Ltd.
- Labeler DUNS
- 544830912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2026-04-01
- Public Version
- 1
- Public Version Date
- 2026-04-09
- Public Version Status
- New
- Public Device Record Key
- 9bbc6807-4758-40ef-8054-8cac83990eef
Device Description
SURFLO MIDELA Midline Catheter Basic Kit
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | General Hospital | 880.5200 | 2 |
| PND | Midline Catheter | General Hospital | 880.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32151 | Peripheral vascular intervention infusion catheter | A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 56927675520758 | GS1 | Large Unit box | 5 | In Commercial Distribution | |
| Primary | 36927675520754 | GS1 | ||||
| Unit of Use | 06927675520753 | GS1 |
Customer Contacts
- Phone
- +1(800)283-7866
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80 | Millimeter | |
| Catheter Gauge | 1.0 | French | |
| Device Size Text, specify | 1.1 MM |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Do not store at extreme temperatures.Fragile, handle with care. Keep away from sunlight. Keep dry .Stacking limit by 5.